Phase 2 Lymphoma Trial, Recruiting NCT05977673 Sponsor: Fondazione Italiana Linfomi - ETS Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05977673
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with a specific type of lymphoma called classical Hodgkin Lymphoma (cHL), confirmed by a tissue biopsy, and who have tissue samples or slides available for the study's central review process.
  • People aged 65 or older who are not considered suitable for the standard chemotherapy normally used as a first treatment, mainly due to other existing health conditions.
  • People who have not yet received any treatment for Hodgkin Lymphoma.
  • People whose lymphoma can be detected on a PET scan and has at least one affected lymph node measuring 1.5 cm or more in its longest dimension.
  • People whose lymphoma requires full-body (systemic) treatment — meaning all disease stages except a very early, small-burden stage that can be cured with radiation therapy alone.
  • People whose general physical health and ability to carry out daily activities falls within an acceptable range for the study (rated 0, 1, or 2 on a standard medical scale).
  • People whose blood counts, kidney function, and liver function meet the minimum levels required by the study.
  • People with a life expectancy of at least 6 months.
  • Men who are sexually active and agree to use effective contraception (such as condoms, vasectomy, or complete abstinence) from the time of signing the consent form until 4 months after the last dose of the study drug.
  • People who are willing and able to give written consent to participate, attend all required study visits, and return to the enrolling hospital for follow-up.

Who may not be able to join:

  • People diagnosed with a different subtype of Hodgkin Lymphoma called nodular lymphocyte predominant Hodgkin Lymphoma.
  • People who have already received any treatment for Hodgkin Lymphoma, including radiation therapy.
  • People who have had an active autoimmune disease requiring systemic treatment within the past 2 years (note: people with well-controlled type 1 diabetes, hypothyroidism managed with hormone replacement only, or controlled coeliac disease are not automatically excluded — confirm with trial site).
  • People with a known history of serious lung conditions such as interstitial lung disease, lung scarring (pulmonary fibrosis), or non-infectious lung inflammation, or who experience breathlessness at rest or have low oxygen levels while breathing normal air.
  • People who have previously been treated with certain types of immunotherapy drugs (anti-PD1, anti-PDL1, anti-PDL2, or anti-CTLA-4 agents) for any condition other than Hodgkin Lymphoma.
  • People who have taken high-dose steroid medications or other immune-suppressing drugs within 14 days before registering for the trial (inhaled or topical steroids at low doses may be acceptable — confirm with trial site).
  • People with a known HIV infection or infection with human T-cell lymphotropic virus type 1 or 2.
  • People with active hepatitis B infection, as determined by specific blood tests (people with past or inactive hepatitis B infection may still be eligible if they are willing to take preventive antiviral medication, and people with hepatitis B immunity from vaccination are not excluded — confirm with trial site).
  • People who test positive for hepatitis C antibodies, unless a follow-up test confirms the hepatitis C virus is not currently active in the blood.
  • People with a known allergy or sensitivity to the study drug, tislelizumab, or any of its ingredients.
  • People with lymphoma that has spread to the brain or the fluid surrounding the brain and spinal cord.
  • People with a serious active infection (viral, bacterial, or fungal), including an active COVID-19 infection.
  • People with other significant uncontrolled illnesses that, in the treating doctor's judgment, would make participation unsafe or interfere with the study results.
  • People who have had major surgery within 4 weeks before the first dose of the study drug.
  • People who have received a live vaccine within 4 weeks before the first dose of the study drug.
  • People with significant heart or cardiovascular problems, including a heart attack within the past 6 months, unstable chest pain within the past 3 months, severe heart failure, certain serious heart rhythm problems, abnormal heart electrical readings, certain types of heart block without a permanent pacemaker, or uncontrolled high blood pressure.
  • People with serious neurological, psychiatric, hormonal, metabolic, immune, or liver conditions that would prevent safe participation or the ability to give informed consent.
  • People who have had another active cancer within the past 3 years (some exceptions apply for certain skin cancers or cancers that were fully removed with surgery — confirm with trial site).
  • People with a history of severe allergic reactions to other similar antibody-based medications.
  • People who are currently participating in another clinical trial involving a treatment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Pier Luigi Zinzani, MD, Istituto di Ematologia "L. e A. Seràgnoli", AOU Policlinico S.Orsola-Malpighi, Bologna

Phone: +390131033153

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Fondazione Italiana Linfomi - ETS
Registry
ClinicalTrials.gov
Start date
23 May 2024
Est. completion
1 November 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Overall Response Rate (CR + PR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov